Simulect

Prevents acute organ rejection. BLA 103764, held by Novartis. Basiliximab.

As of Nov 13, 2026, BLA 103764 (Simulect), held by Novartis, was first approved by FDA on May 12, 1998, with 7 approved supplements and 0 published complete response letters.

First approved: May 12, 1998
Review: Priority
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Simulect (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Mar 23, 2001	Supplement 5003Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 22, 2001	Supplement 1010Efficacy (new indication or use) · Standard review	Approved	None posted
May 12, 1998	Original applicationNew molecular entity · Priority review	Approved	Label Letter

Products

2 strengths and forms

Product	Active ingredient	Marketing
Simulect10MG · vial; single-use	Basiliximab	Rx
Simulect20MG · vial; single-use	Basiliximab	Rx

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 15, 2005	Supplement 5059Labeling · Standard review	Approved	None posted
Nov 14, 2003	Supplement 5040Labeling · Standard review	Approved	Letter
May 27, 2003	Supplement 5046Labeling · Standard review	Approved	None posted
Jan 2, 2003	Supplement 5037	Approved	Letter Label
Nov 29, 2001	Supplement 5006Labeling · Standard review	Approved	None posted
Mar 23, 2001	Supplement 5003Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 22, 2001	Supplement 1010Efficacy (new indication or use) · Standard review	Approved	None posted
May 12, 1998	Original applicationNew molecular entity · Priority review	Approved	Label Letter

Identifiers

Application: BLA 103764
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters